French Public Health Code
In forceI.-The request for an import authorisation sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail must indicate :
1° The name or corporate name, address and position of the natural or legal person responsible for the import ;
2° The country of origin and, if different, the country where the veterinary medicinal product was manufactured, and where appropriate the name and address of the manufacturer;
3° The name of the veterinary medicinal product imported, its composition, pharmaceutical form, strength, route of administration and the animal or animals of destination;
4° The quantities imported;
5° The desired duration of import operations;
6° The purpose of the import.
II - The application is submitted :
1° By a veterinarian or a pharmacist, at the request of the person responsible for the care of the animal or animals, for medicinal products intended for animals whose flesh or products are intended for human consumption or for veterinary medicinal products intended for animals whose flesh or products are not intended for human consumption and covered by a compulsory prescription in accordance with French legislation ;
2° Directly by the person responsible for the care of the animal or animals, in the case of veterinary medicinal products intended for animals whose flesh or products are not intended for human consumption and not covered by a compulsory prescription in accordance with French legislation;
3° By the pharmacist or veterinary surgeon in charge of a veterinary pharmaceutical establishment mentioned in article L. 5142-1 ;
4° By the promoter of a clinical trial or by the person in charge of an experiment.
III-This application also includes, depending on the case, the following information or documents:
1° For veterinary medicinal products imported with a view to a clinical trial, the name and address of the veterinary pharmaceutical establishment carrying out the import or distribution operations, authorised in application of article L. 5142-2.
2° For veterinary medicinal products imported with a view to a non-clinical trial, the justification and protocol for the experiment, a copy of the authorisation to experiment provided for in article R. 214-93 of the Rural and Maritime Fishing Code obtained by the person responsible for the experiment and the copy of the approval of the experimentation establishment provided for in article R. 214-103 of the same code. </p><p>3° For veterinary medicinal products covered by the regulations on narcotics or psychotropic substances, a copy of the authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé provided for by Article R. 5132-78 or Article R. 5132-92.
4° For imported veterinary medicinal products, under the conditions provided for in a of II of this article, the prescription prescribing the veterinary medicinal product pursuant to the provisions of article L. 5143-4.
5° For medicated feedingstuffs other than those mentioned in 2° of Article L. 5142-7:
a) The name of the medicated premix, its composition, the intended animals and, where applicable, a copy of the marketing authorisation issued by the country of origin ;
b) The name of the medicated feed, the rate of incorporation of the premix and the qualitative and quantitative composition of the feed fraction.
